MiRus announced new early feasibility study results supporting the use of its Siegel transcatheter aortic valve replacement (TAVR) system.
Dr. Pradeep Yadav (Piedmont Heart Institute) and Dr. Raj Makkar (Cedars Sinai) presented findings in podium presentations at NY Valves. Thirty-day results came from the company’s U.S. early feasibility study (EFS). MiRus announced the start of the study at the end of March.
In the study, investigators treated 15 patients with severe, symptomatic aortic stenosis (AS) across five sites. At 30 days, they reported zero deaths, strokes or re-hospitalizations. No patients had vascular complications, paravalvular leak (PVL) or required a permanent pacemaker.
MiRus says Siegel offers several firsts in TAVR, with its 8 Fr delivery sheath allowing less invasive procedures and broader patient access, particularly for women. As the only nickel-free THV system, it allows for the treatment of the 20% of Americans suffering from nickel allergies.
Siegel also offers precise delivery due to a lack of foreshortening and intrinsic commissural alignment. Its dry porcine pericardial leaflets have anti-calcification treatment and it has a pre-mounted valve on the balloon.
MiRus engineered the system with its Rhenium alloys. These alloys feature unique properties that help enable the combination of a low delivery system profile and strong hemodynamics. The company says it offers high yield strength, fatigue resistance and minimal recoil.
“This is the first TAVR to have no foreshortening during implantation and along with small vascular access, makes it very user friendly and should also lead to fewer pacemakers and vascular complications” said Yadav. “The lack of nickel is also very appealing – we were able to treat a patient with severe nickel and cobalt allergy.”
